Just what we didn’t need
On the same day when the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health stopped the intensive treatment arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study due to an increased risk of death, the New England Journal of Medicine publishes a study “Effect of a Mutifactorial Intervention on Mortality in Type 2 Diabetes”, which appears to contradict the what the NHLBI found with ACCORD.
According to the study in the NEJM, “In at-risk patients with type 2 diabetes, intensive intervention with multiple drug combinations and behavior modification had sustained beneficial effects with respect to vascular complications and on rates of death from any cause and from cardiovascular causes.” It should be noted that the defined target for the intensive therapy group was an A1C of less than 6.5%, which is consistent with the target used in the ACCORD study for their intensive therapy arm.
The study goes onto to state; “After a mean of 13.3 years (7.8 years of multifactorial intervention and an additional 5.5 years of follow-up), there was an absolute risk reduction for death from any cause of 20% among patients with type 2 diabetes and microalbuminuria who received intensive therapy, as compared with those who received conventional therapy. The absolute risk of death from cardiovascular causes was reduced by 13% among those receiving intensive therapy. During the entire follow-up period, the rate of death among patients in the conventional-therapy group was 50%, a finding that underscores the poor prognosis for such patients in the absence of intensive treatment.”
Interestingly the authors of the study state; “The drugs used in our study differed between the study groups. For instance, a larger proportion of patients in the intensive-therapy group took metformin or sulfonylurea, despite the similar levels of glycemia in the two groups. Therefore, differences in drugs or their combinations might have contributed to the long-term outcome.” Notably absent here is the usage of any thiazolidinediones (TZD’s) , a drug used in the ACCORD study which used TZD’s, primarily rosiglitazone (Avandia).
These two contradictory results will only create more questions and add to the confusion in the diabetes community. There are some who will surly point that ACCORD patients were taking Avandia, a drug that carries a black box warning regarding cardiovascular risk. Others will accurately point out that patients in ACCORD were classified as high risk while the patients in the Steno-2 study had type 2 diabetes and persistent microalbuminuria. The ACCORD enrolled 10,251 patients, Steno-2 160. There are other differences as well, however, the fact that one study had to stop the intensive therapy arm while the other found intensive therapy was beneficial makes matters worse not better.
While the NHLBI stated that they found no conclusive evidence that no one drug was associated with the increased rate of death, it will be interesting to see more detailed data when the data is published.
One thing is certain, even with the differences in the two studies, the different results will only create more confusion. Already bombarded with confusing information patients and their physicians are once again left to their own devices. While Diabetic Investor firmly believes in the benefits of tight glucose control we are also well aware of just how difficult it is to achieve control. The fact is achieving an A1C of 7% or below is hard work and requires more than just taking being compliant in taking medications. To reach control patients must monitor their glucose levels on a regular basis, watch what they eat, exercise and be mindful of hypoglycemia. Diabetes is 24x7x365 job with no days off.
It’s no accident that another study found that patients would rather sacrifice years off their lives then put up with all the things they need to do to control their diabetes. Diabetes is not like a headache or fever when after treatment the patient “feels” better. It is possible, even likely, that a patient under good control will feel no different than one who is not.
This is why Diabetic Investor has consistently favored treatments and technologies that make life easier for the patient. This is also why we are strong believers in the once-a-week version of Byetta. Besides providing excellent glycemic control and producing significant weight loss, patients on Byetta LAR do not need to check their glucose levels on a regular basis or watch everything they eat. Add in the fact that Byetta LAR is taken just once a week, at the same dose each week and you can begin to understand why physicians are anxiously awaiting it’s arrival. Byetta LAR will not work with every patient but has the potential to be paradigm changing technology.
We should also point that managing diabetes is a much an art as it is a science. Different patients require different treatment regimens. This fascination with a one-size fits all approach just reinforces the lack of understanding there is in the physician community on how to effectively treat diabetes. With over 80% of patients being treated by a primary care physician it is just as important that these physicians who treat patients be properly educated on diabetes. How can you ask patients to consult with their physician when the physician lacks the knowledge to properly assist the patient.
Even if the physician is well informed what will they tell patients when one study finds one thing and another finds the exact opposite. Given the dynamics of diabetes it’s easy to see understand why nearly two-thirds of patients with diabetes are not under control. The system is badly broken, the cost are enormous and with the epidemic growth rate of both diabetes and pre-diabetes the situation is only going to get worse.